Quality Systems GxP Training Specialist II

This role is a core member of the Quality Systems team and works on activities and tasks that support the GxP training program. This role requires an adaptable, self-starter that can independently assess issues and propose solutions for systems like ComplianceWire used to manage training compliance. This position reports to the Sr. Manager of Document Control and GxP Training.

Responsibilities:

• Perform administrative tasks in the LMS including creation of training items or curricula, support for system enhancements, troubleshooting issues with user accounts or training access, and monitoring and sharing reports to drive training compliance
• Support cross-functional GxP Training Leads in strengthening training compliance using instructor led training, reports and metrics, and education on GxP training matrix
• Assess training qualification materials, including but not limited to SOPs and work instructions, ensuring they are appropriately added into training curricula across various GxP departments
• Assess existing curricula to determine if additional training items, like work instructions, should be added to support learning
• Support onboarding activities by working with HR, IT, and managers to identify training roles and requirements prior to making assignments in the LMS
• Support hiring managers in their understanding of the GxP training matrix and work with GxP Training Leads to determine if revisions are required
• Support supplemental training activities including on-the-job training and instructor-led training
• Collect and report training metrics using reporting functionality in the LMS
• Design dashboards to expand visibility on training compliance at the department level
• Identify and escalate gaps and discrepancies in the GxP training program and propose solutions for remediation
• Assist with training attendance records and cataloging and filing activities, as well as uploading completed forms into the Learning Management System (LMS)
• Assist in the implementation of new LMS enhancements or systems
• Capture detailed meeting minutes, action items, and key decisions
• Assist in drafting internal communications for events and training status reports
• Coordinate and schedule lunch and learn training sessions, office hours, and other supplemental training events
• Promptly respond to email inquiries and user support questions using ticketing systems like Zendesk

Preferred Skills, Qualifications and Technical Proficiencies:

• Experience with electronic Learning Management Systems (ComplianceWire LMS and Veeva Training preferred)
• Experience supporting GxP training programs for life sciences
• Proficient in the use of MS Office applications (Excel, Word, Visio, Teams)
• Excellent organizational skills and the ability to manage multiple competing tasks
• Excellent communication skills with the ability to collaborate with a wide range of stakeholders in various departments

Preferred Education and Experience:

• BA/BS degree in a scientific/technical/engineering field
• 3+ years of experience in pharmaceutical or life sciences organizations

The pay range that the Company reasonably expects to pay for this headquarters-based position is $87,000 – $102,400; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.